A summary of study results
"A clinical trial is not just a single marathon; it is a series of marathons run repeatedly in slightly different landscapes. Even if you achieve one goal, there may be several journeys still ahead, along with new ones yet to come." - Mikko Kylmänen, Research Officer, Koite Health Ltd
Read more about Lumoral research at lumoralpro.com
A randomised clinical trial on periodontitis (interim report): 57/200 subjects, in 2022
The largest periodontal study in Europe shows that periodontal treatment outcomes improve significantly when daily Lumoral treatment is added to the routine of periodontal home care.
In 54% of Lumoral users, the gingival inflammation index (BOP), an indicator of inflammation, was reduced to healthy levels (BOP less than 10%). Two out of three (67%) patients treated with Lumoral had at least half the number of deep gingival pockets compared to baseline. This result was significantly better than in the control group. Four patients in the Lumoral group had no deep gingival pockets at the end of the period.
A randomised clinical trial on peri-implantitis: 40 subjects, in 2022, (submitted)
The study found consistent findings and clear differences between the groups. In subjects of the Lumoral group, a reduction in plaque, a reduction in gum bleeding, and a reduction in gingival pockets were observed.
A randomised study of elderly people living in 24-hour care facilities: 31 subjects, in 2023
The study found that light-activated Lumoral treatment improves oral health in 24-hour care home residents as part of a regular oral hygiene routine. The Lumoral group had better oral hygiene as well as better oral moisture (objectively and subjectively assessed).
A pilot study on peri-implantitis: 7 subjects, in 2022
In 2022, Hanna Lähteenmäki, a Lumoral researcher and President of the Finnish Association of Dental Hygienists, published the results of a pilot study showing that Lumoral treatment has also shown promising results in the treatment of dental implant-related infections. According to Lähteenmäki, the amount of plaque and gum bleeding in patients were significantly reduced compared to baseline, and there were no side effects associated with Lumoral. In this study, the effect of Lumoral on the inflammatory marker aMMP-8, which indicates periodontal disease, has been of interest.
Lumoral, a dual light-based therapy, is a medical device for the treatment of gingivitis and periodontitis and the prevention of tooth decay. The method effectively removes plaque and prevents the formation of tartar.
A case report of a periodontitis patient: a 78-year-old person, in 2022.
A case report on a 78-year-old male patient with vascular dementia found that Lumoral antibacterial treatment was effective in eliminating harmful oral bacteria while also treating advanced gum disease. Recovery from severe periodontal disease over a 13-month follow-up period was excellent, the study reveals. Oral hygiene improved markedly and the number of infected gum pockets decreased significantly. In addition, clinical adherence improved. Only one infected periodontal pocket remained. This can be argued to be at least partly due to occlusal trauma, the researchers point out.
A plaque study in healthy adults, randomised: 15 subjects, in 2023
A plaque study carried out by students of oral hygiene at the Metropolia University of Applied Sciences, in Helsinki, found that using Lumoral twice a week is also beneficial for people in good health. The study also revealed that biofilm reduction was significantly greater in the experimental group of Lumoral users than in the control group.
The aim of the study was to investigate the effectiveness of the antimicrobial Lumoral method in reducing oral biofilm as part of oral self-care in healthy volunteers aged 18-70 years.
Ongoing clinical studies
Please note that this listing does not include previously published studies.
Sponsored / investigator-initiated; Investigators
Number of targeted participants (status)
Sponsored.
Investigators: Saila Pakarinen, Timo Sorsa, Riitta Saarela, Petri Auvinen, Taina Tervahartiala
200 (active, follow-up)
Sponsored.
Investigators: Ann-Marie Roos Jansåker, Katja Elses, Vanessa Larsson
40 (active, follow-up)
Sponsored.
Investigators: Anna Maria Heikkinen, Kati Ylä-Tuuhonen, Katja Rauhala, Timo Sorsa, Jaana Hagström, Ulla Kotiranta, Taina Tervahartiala, Esko Kankuri
60 (active, recruiting)
Sponsored.
Investigators: Ingrida Pacauskiene, Nomeda Basevičienė, Vita Mačiulskienė, Raimonda Guntulytė, Alma Pranckevičienė, Timo Sorsa, Ismo Räisänen, Petri Auvinen
60 (active, recruiting)
Investigator-initiated.
Investigators: Anna Maria Heikkinen, Millamari Sarja, Satu Kapanen, Teija Raivisto, Timo Kauppila, Ismo Räisänen, Tommi Pätilä, Timo Sorsa, Saila Pakarinen, Essi Teronen, Mikko Kylmänen
120 (active, recruiting)
Investigator-initiated.
Investigators: Nilminie Rathnayake, Timo Sorsa, Akke Kumlien, Monika Kala, Tommi Pätilä
80 (active, recruiting)
Investigator-initiated.
Investigators: Harri Niskanen, Timo Sorsa, Katja Gustafsson, Karim Abdalla, Pekka Kallio
100 (active, recruiting)
Investigator-initiated.
Investigators: Anna Maria Heikkinen, Patrick Saikkonen, Laura Mealonen, Miia Ehrnrooth, Timo Sorsa, Atte Vadén, Andreas Pfuetzner, Marko Helenius, Pirkko Pussinen, Timo Kauppila
150 (active, recruiting)
Investigator-initiated.
Investigators: Paolo Giacomo Arduino, Elio Berutti, Giuseppe Garlo Iorio, Umberto Ricardi, Gugliemo Ramieri, Paolo Garzino Demo, Tommaso Mairano, Alessio Gambino, Giorgia El Haddad
60 (active, recruiting)
Investigator-initiated.
Ulla Marjosola, Minna Elomaa-Krapu, Maarit Valtonen, Tommi Pätilä, Pekka Ruuska, Mikko Kylmänen
36 (in ethical review, planned start Q1/2025)
Investigator-initiated.
Investigators: Prof. Alberto De Biase, Prof.ssa Anna Scotto d’Abusco, Dr. Marco Lollobrigida, Dr. Giulia Mazzucchi, Dr. Alessia Mariano
30 (active, recruiting)
Investigator-initiated.
Investigators: Vanessa Faber, Prof. Werner Birglechner
52 (active, recruiting)
Sponsored.
Investigators: Timo Sorsa, Paula Tegelberg, Meeri Ojala, Merja Ylipalosaari, Jori Lindroth, Petri Auvinen
90 (recruitment completed, data analysis)
Investigator-initiated.
Investigators: Hellevi Ruokonen, Karita Nylund, Nina-Li Avellan, Patricia Stoor, Kirsten Besuch, Viivi Mattila
80 (active, follow-up)
Investigator-initiated.
Investigators: Elisa Ronkainen, Juho Suojanen, Timo Sorsa, Junnu Leikola, Arja Heliövaara, Taina Tervahartiala
15-20 (recruitment completed, data analysis)
Investigator-initiated.
Investigators: Dimitra Sakellari, Chrysoula Vakaki, Veta Doufexi, Timo Sorsa, Ismo Räisänen, Tommi Pätilä
60 (recruitment completed, data analysis)
Investigator-initiated.
Investigators: Riina Rünnel, Laura Gusseva, Liisa Lill
30 (recruitment completed, report writing)
Investigator-initiated.
Investigators: Riitta Saarela, Timo Sorsa, Saila Pakarinen, Jaana Helenius-Hietala, Wilma Romppainen, Sanna Korte, Tuuli Seitsamo, Taina Tervahartiala
40 (recruitment completed, report in peer review)
Investigator-initiated.
Investigators: Hanna Lähteenmäki, Timo Sorsa, Taina Tervahartiala, Tommi Pätilä, Ismo Räisänen
40 (recruitment completed, report in peer review)
The importance of research
Clinical device research is essential to ensure that healthcare devices are safe, effective, and meet the necessary performance standards. High-quality clinical trials, grounded in scientific evaluation, provide both users and healthcare professionals with confidence in the safety, reliability, and effectiveness of medical devices.
Standards are the foundation of clinical research
International standards are the cornerstones of the clinical study designs for Lumoral. These include ISO 14155 GCP (Clinical Trials on Medical Devices - Good Clinical Practice) and the European Union's Medical Device Regulation EU 2017/745 (MDR). A clinical trial for Lumoral should have clear goals and objectives, either to confirm that the treatment's effects align with the already approved marketing authorization or to explore new uses for Lumoral. Strict regulatory compliance will ensure that the safety of participants in the studies is maintained.
Driving innovation
Lumoral's research opens up new possibilities for the development of oral care. Our company is proud to be able to promote health and well-being through innovative solutions.
Ongoing and completed studies highlight the diverse applications of Lumoral in enhancing oral health across various populations and conditions.
Lumoral: New Advances in the Scientific Research of Antibacterial Lumoral Treatment
The Finnish oral health innovation, Lumoral, has sparked significant interest in the academic community, with several new studies launching in recent months. Mikko Kylmänen, Research Manager at Koi...
In research cooperation with
